- QA/QC impact: The new Ph. Eur. chapter gives immunoglobulin laboratories a defined framework for procoagulant activity testing before July 2027.
- Regulatory impact: Revised IVIG and SCIG monographs will point to the new chapter, creating a direct compendial change for affected products.
- Validation impact: Laboratories should assess how the described methods, controls, and matrix considerations fit their current testing procedures.
Three New Ph. Eur. Tests Could Change Immunoglobulin QC
EDQM says activated human coagulation factor XI, or FXIa, typically causes procoagulant activity in immunoglobulin preparations. Therefore, the new chapter describes three methods that laboratories can use to detect this activity.
The chromogenic substrate assay, or CSA, specifically detects FXIa. In addition, the thrombin generation assay, or TGA, and the non-activated partial thromboplastin time assay, or NAPTT, can detect other potential procoagulant impurities.
Importantly, the chapter does more than identify test methods. It also addresses matrix effects, appropriate controls, and the selection of suitable substrate plasma. As a result, laboratories receive clearer pharmacopoeial direction for implementing the testing approach.
EDQM also revised the monographs for Human normal immunoglobulin for intravenous administration (0918) and Human normal immunoglobulin for subcutaneous administration (2788). Both will reference General Chapter 2.6.42 and appear with it in Issue 13.3.
QC Labs Now Have Until July 2027 to Prepare for the New Ph. Eur. Chapter
For affected teams, the key decision is when to begin preparing for July 2027. Rather than waiting for the effective date, laboratories can review current procedures, compare existing controls with the new chapter, document identified gaps, and determine what implementation or method verification work may be appropriate.
The following table provides a practical readiness view rather than additional EDQM requirements.
| Role | Main risk | Practical action | Evidence to retain | Timing |
|---|---|---|---|---|
|
QC |
Current approach may not align with Chapter 2.6.42 |
Assess CSA, TGA and NAPTT applicability |
Gap assessment and method records |
Before 1 July 2027 |
|
QA |
Compendial change may enter the quality system late |
Manage the update through change control |
Approved change record |
Before 1 July 2027 |
|
Regulatory Affairs |
IVIG/SCIG documentation may require review |
Assess the revised monographs |
Regulatory impact assessment |
Before 1 July 2027 |
EDQM developed the chapter from two collaborative studies. One examined the CSA and has already appeared in Pharmeuropa Bio & Scientific Notes. Meanwhile, EDQM says a separate publication will present the TGA study. Consequently, the next milestones to watch are Issue 13.3 in October 2026, the forthcoming TGA publication, and the 1 July 2027 effective date.
Expert check: If your laboratory already tests procoagulant activity, would you wait for the effective date or start a documented gap assessment now?
For teams preparing laboratory methods and GMP-controlled systems for new compendial expectations, Zamann Pharma Support’s Qualification and Validation for GMP-Regulated Systems provides hands-on lifecycle support for compliant qualification and validation. If your team needs practical support turning new requirements into controlled and documented implementation, explore the service.
Source: Edqm.Eu